Inspection readiness is the state of being always prepared for a regulatory inspection (and audits). Achieving a favourable outcome from an audit, and especially a regulatory inspection, demonstrates compliance with the applicable GxP regulations of that organisation. Therefore, being ready to successfully host inspections shows that not only does an organisation understand the regulatory applicable to them but that they applied this knowledge correctly to the development of their quality management system (QMS), and the data they have generated. This post will cover the mechanisms for assessing compliance internally.
Processes that demonstrate compliance
During an inspection an inspector will review a selection of data, documentation, and processes from across multiple studies and business areas. Inspectors will be looking for evidence of:
- robust QMS
- effective training program
- risk management and process control
- comprehensive supplier and vendor management
- validation and qualification procedures of equipment
- data integrity and documentation practices
- efficient record keeping
Assessing inspection readiness
Organisations within GxP regulatory environments should use internal procedures to monitor compliance and assess whether they are inspection ready.
- A comprehensive Quality Assurance (QA) program should provide oversight of all the operations of the organisation. It might not be practical for QA to audit all procedures therefore a selection of procedures should audit based on risk
- The controlled documents that make up the QMS should be routinely reviewed to make sure they are in line with regulatory requirements
- Effective management of quality events including CAPAs should be prioritised to make sure they are addressed properly. The outcomes of quality events should be fully documented, and actions implemented comprehensive
- Gap analysis and change control should be performed to check that the organisation is within compliance when there are changes internally or externally. The outcome of these internal quality processes should be report to management for review and trend analysis
To conclude, inspection readiness is based on the compliance of the applicable GxP regulations. Inspectors will look for evidence of compliance in the organisations QMS and data generated. An organisation can monitor their compliance by having effective quality oversight of these processes.
